by: ASRM Office of Public Affairs
Published in ASRM Bulletin
FDA's Cellular, Tissues and Gene Therapies Advisory Committee met yesterday and is continuing today to discuss oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility.
Several ASRM members were invited to the committee as special members for this meeting and others are giving presentations. Prior to the meeting, ASRM submitted the following comment:
To: Cellular, Tissues and Gene Therapies Advisory Committee
From: American Society for Reproductive Medicine
The American Society for Reproductive Medicine (ASRM) is a multi-disciplinary organization whose members are physicians, scientists and other health care professionals involved in the field of reproductive medicine. We appreciate the opportunity to provide comments to the Committee regarding oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility. ASRM has always recognized that research and clinical practice involving human reproduction and infertility must take into account the unique nature of the tissues, cells and organisms involved in the creation of new life. We believe the science behind oocyte manipulation to transfer mitochondria is interesting and has promise in treating infertility and preventing the transmission of mitochondrial disease, which are both important goals. We believe further research in this area is important, and could have clinical applications. We encourage and support FDA's efforts to determine how to proceed with evaluating its safety and efficacy, and we would be happy to consult with FDA in pursuing this.
The meeting agenda and materials are available on FDA's website at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials
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